Phase
Condition
Macular Degeneration
Geographic Atrophy
Treatment
Port Delivery Platform
Ranibizumab
Zifibancimig
Clinical Study ID
Ages > 50 All Genders
Study Summary
Eligibility Criteria
Inclusion
Part 1, Part 2 and Part 3 Inclusion Criteria:
- Willing to allow AH collection.
Part 1 and Part 2 Ocular Inclusion Criteria for Study Eye:
Choroidal neovascularization (CNV) exclusively due to age-related macular degeneration (AMD).
Anti-vascular endothelial growth factor (VEGF) or anti-VEGF/Angiopoietin-2 (Ang-2) IVT treatment-naïve, or pre-treated with anti-VEGF or anti-VEGF/Ang-2 no less than two months prior to Day 1.
Sufficiently clear ocular media and adequate pupillary dilatation to allow for analysis and grading by the central reading center of fundus photography (FP), fluorescein angiography (FA), fundus autofluorescence (FAF), and spectral domain optical coherence tomography (SD-OCT) images.
Decreased BCVA attributable primarily to nAMD, with BCVA letter score of 78 to 34 letters (inclusive) on ETDRS-like charts at screening. In case both eyes of a participant are eligible, the eye with the lower BCVA score should become the study eye.
Part 3 Ocular Inclusion Criteria for Study Eye:
CNV exclusively due to AMD.
Diagnosis of nAMD within 36-months prior to the screening visit.
Previous treatment with at least one IVT anti-VEGF or anti-VEGF/Ang-2 administrations IVT for nAMD. The last IVT administration must have occurred at least 21 days prior to the screening visit.
Demonstrated response to prior IVT anti-VEGF or anti-VEGF/Ang-2 treatment since diagnosis.
Availability of historical VA data prior to the first anti-VEGF or anti-VEGF/Ang-2 treatment for nAMD.
Sufficiently clear ocular media and adequate pupillary dilatation to allow for analysis and grading.
Decreased BCVA attributable primarily to nAMD with letter score of 78 to 34 letters (inclusive) or better on ETDRS-like charts.
Ocular Exclusion Criteria for Study Eye:
History of vitrectomy surgery, submacular surgery, other intraocular surgery, or any planned surgical intervention during the study period.
Cataract surgery without complications within three months preceding the screening visit or planned during the study period.
Aphakia or absence of the posterior capsule. Previous violation of the posterior capsule is also an exclusion criterion, unless it occurred as a result of yttrium-aluminum garnet laser posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation.
Prior macular treatment with verteporfin, external beam radiation therapy, transpupillary thermotherapy, or any type of laser photocoagulation.
Prior treatment with IVT corticosteroids or implant (e.g., triamcinolone, ozurdex, iluvien).
Subretinal hemorrhage >50% of the total lesion area and/or involving the fovea.
Subfoveal fibrosis or subfoveal atrophy.
Retinal pigment epithelial tear involving the macula.
History of vitreous hemorrhage, rhegmatogenous retinal detachment, glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery, and corneal transplant.
History of rhegmatogenous retinal tears or peripheral retinal breaks within three months prior to the screening visit.
Actual or history of myopia >-8 diopters.
Uncontrolled ocular hypertension or glaucoma (defined as intraocular pressure (IOP) >25 millimeters of mercury (mm Hg) or a cup to disc ration >0.8, despite treatment with antiglaucoma medication) and any such condition the Investigator determines may require a glaucoma-filtering surgery during a participant's participation in the study.
Concurrent intraocular conditions (e.g., cataract, diabetic retinopathy, epiretinal membrane with traction, macular hole) that, in the opinion of the Investigator, could either:
Require medical or surgical intervention during the study period to prevent or treat visual loss that might result from that condition; or
Likely contribute to loss of BCVA over the study period if allowed to progress untreated; or
Preclude any visual improvement due to substantial structural damage.
Concurrent conjunctival, Tenon's capsule, and/or scleral condition in the supero-temporal quadrant of the eye (e.g., scarring, thinning, mass) that may affect the implantation, subsequent tissue coverage, and refill-exchange procedure of the PD implant.
Prior treatment with any medication for geographic atrophy during the last 3 months prior to screening.
Prior treatment with any anti-VEGF-C or anti-VEGF-D inhibitors.
Exclusion Criteria for Fellow Eye
BCVA letter score using ETDRS charts of < 34 letters.
Treatment with IVT anti-VEGF or anti-VEGF/Ang-2 agents within one week prior to Day 1 (concurrent treatment with SUSVIMO^TM in the fellow eye is not exclusionary).
Exclusion Criteria for Either Eye
CNV due to causes other than nAMD, such as ocular histoplasmosis, trauma, pathological myopia, angioid streaks, choroidal rupture, uveitis or central serous chorioretinopathy.
Prior participation in a clinical trial involving anti-VEGF drugs within six months prior to the screening visit, other than ranibizumab, aflibercept, or faricimab including approved biosimilars.
Active intraocular inflammation (grade trace or above), infectious conjunctivitis, keratitis, scleritis, or endophthalmitis.
History of uveitis, including history of any intraocular inflammation following intravitreal therapy.
Prior treatment with brolucizumab.
Prior gene therapy for nAMD
Study Design
Connect with a study center
Emanuelli Research and Development Center LLC
Arecibo, 00612
Puerto RicoActive - Recruiting
Barnet Dulaney Perkins Eye Center
Mesa, Arizona 85206
United StatesActive - Recruiting
Associated Retina Consultants
Phoenix, Arizona 85020
United StatesSite Not Available
The Retina Partners
Encino, California 91436
United StatesActive - Recruiting
Retinal Consultants Med Group
Sacramento, California 95841
United StatesActive - Recruiting
West Coast Retina Medical Group
San Francisco, California 94109
United StatesActive - Recruiting
Orange County Retina Med Group
Santa Ana, California 92705
United StatesActive - Recruiting
Southwest Retina Consultants
Durango, Colorado 81303
United StatesActive - Recruiting
Retina Specialty Institute
Pensacola, Florida 32503
United StatesActive - Recruiting
Retina Vitreous Assoc of FL
Saint Petersburg, Florida 33711
United StatesActive - Recruiting
Southern Vitreoretinal Assoc
Tallahassee, Florida 32308
United StatesActive - Recruiting
Retina Associates of Florida, LLC
Tampa, Florida 33609
United StatesActive - Recruiting
Southeast Retina Center
Augusta, Georgia 30909
United StatesActive - Recruiting
University Retina and Macula Associates, PC
Oak Forest, Illinois 60452
United StatesActive - Recruiting
Retina Associates
Lenexa, Kansas 66215
United StatesSite Not Available
Maine Eye Center
Portland, Maine 04101
United StatesActive - Recruiting
Johns Hopkins Med
Baltimore, Maryland 21287
United StatesActive - Recruiting
The Retina Care Center
Baltimore, Maryland 21209
United StatesActive - Recruiting
Retina Group of Washington
Chevy Chase, Maryland 20815
United StatesActive - Recruiting
Cumberland Valley Retina Associates
Hagerstown, Maryland 21740
United StatesActive - Recruiting
Cumberland Valley Retina Consultants
Hagerstown, Maryland 21740
United StatesActive - Recruiting
Foundation for Vision Research
Grand Rapids, Michigan 49546
United StatesActive - Recruiting
Associated Retinal Consultants
Royal Oak, Michigan 48073
United StatesActive - Recruiting
VitreoRetinal Surgery, PLLC.
Edina, Minnesota 55435
United StatesActive - Recruiting
Midwest Vision Research Foundation
Chesterfield, Missouri 63017
United StatesActive - Recruiting
The Retina Institute
Saint Louis, Missouri 63128
United StatesActive - Recruiting
Sierra Eye Associates
Reno, Nevada 89502
United StatesSite Not Available
Envision Ocular, LLC
Bloomfield, New Jersey 07003
United StatesSite Not Available
Mid Atlantic Retina - Wills Eye Hospital
Cherry Hill, New Jersey 08034
United StatesSite Not Available
Long Is. Vitreoretinal Consult
Hauppauge, New York 11788
United StatesActive - Recruiting
Retina Vit Surgeons/Central NY
Liverpool, New York 13088
United StatesActive - Recruiting
Graystone Eye
Hickory, North Carolina 28602
United StatesActive - Recruiting
The Cleveland Clinic Foundation
Cleveland, Ohio 44195
United StatesActive - Recruiting
OSU Eye Physicians & Surgeons
Columbus, Ohio 43212
United StatesActive - Recruiting
Mid Atlantic Retina - Wills Eye Hospital
Philadelphia, Pennsylvania 19107
United StatesActive - Recruiting
Charleston Neuroscience Inst
Ladson, South Carolina 39456
United StatesActive - Recruiting
Charles Retina Institute
Germantown, Tennessee 38138
United StatesActive - Recruiting
Southeastern Retina Associates
Knoxville, Tennessee 37923
United StatesActive - Recruiting
Tennessee Retina PC.
Nashville, Tennessee 37203
United StatesActive - Recruiting
Retina Res Institute of Texas
Abilene, Texas 79606
United StatesActive - Recruiting
Austin Clinical Research LLC
Austin, Texas 78750
United StatesActive - Recruiting
Austin Research Center for Retina
Austin, Texas 78705
United StatesActive - Recruiting
Retina & Vitreous of Texas
Bellaire, Texas 77401
United StatesActive - Recruiting
Retina Consultants of Texas
Bellaire, Texas 77401
United StatesSite Not Available
Retina Consultants of Texas
Houston, Texas 77030
United StatesSite Not Available
Brown Retina Institute
San Antonio, Texas 78251-4551
United StatesActive - Recruiting
Retina Center of Texas
Southlake, Texas 76092
United StatesActive - Recruiting
Retina Consultants of Texas
The Woodlands, Texas 77384-4167
United StatesSite Not Available
Piedmont Eye Center
Lynchburg, Virginia 24502
United StatesActive - Recruiting
Wagner Kapoor Institute
Norfolk, Virginia 23502
United StatesActive - Recruiting
Spokane Eye Clinical Research
Spokane, Washington 99204
United StatesActive - Recruiting
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